Bblcrystal Neisseria/Haemophilus (N/H) System

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K962423 ↗

FDA Product Code

JST

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gcii Agar with Isovitalx(R) Enrichment

  Class II

  FDA 510(k) K945569 Active Cleared 2 Feb 1995

• Fosfomycin, 200 Mg, Sensi-Disc

  Class II

  FDA 510(k) K972098 Active Cleared 28 Jul 1997

• Meropenem, 10 Mcg, Sensi-Disc Open recall

  Class II

  FDA 510(k) K963845 Active Cleared 25 Oct 1996

• Enterococcus Screening Medium

  Class II

  FDA 510(k) K951539 Active Cleared 13 Jun 1995

• Sparflozacin, 5 Mcg, Sensi-Disc

  Class II

  FDA 510(k) K970385 Active Cleared 10 Mar 1997

• Crystal Enteric/Nonfermenter Id System

  Class I

  FDA 510(k) K926018 Active Cleared 11 Mar 1993

See all devices from Becton Dickinson Microbiology Systems →